By Len Monheit
In most years with Natural Products Expo concluded, many would now be following up leads and contacts from the show, honoring commitments, filling channels with product, or concluding the agreements initiated in Anaheim.
This year there are other priorities too.
Wasn’t it ironic that as industry members gathered for the industry’s largest North American event, FDA issued its current Good Manufacturing Practices (cGMP) guidelines for the dietary supplements industry? A short 90-day comment period is provided and a 3 year phase-in is proposed.
And we are now into the 30-day comment period on regulations regarding mandatory ephedra labeling with hints that based on comments received in this 30-day period, FDA’s DSHEA authority may be examined in a much broader sense, possibly setting the stage for a complete opening of the 1994 legislation..
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And on yet another front, some are anticipating the impact of the Public Health Security and Bioterrorism Preparedness and Response Act set to apply in October of this year with advance shipment warnings and mandatory facility registration.
That the dietary supplements part of our industry is up against a masterful strategy is beyond doubt. What to do to counter the strategy is less clear, and was the subject of several discussions and presentations at Expo West and Nutracon this past week.
The FDA GMP press release notes they ‘are proposing a new regulation’, which ‘would, for the first time, establish standards’. The entire position of the release suggests that this action on the part of the FDA is in response to the irresponsibility of the industry to manage quality, and not what was required of the FDA as part of DSHEA.
The release is a well prepared piece, designed to continue to prove the industry incapable of managing itself, feeding on perceptions of ‘mavericks’ interested only in short term gains, grown fat at the expense of its customers.
Trade Associations have begun to interpret the guidelines, with calls and webcasts scheduled to members this week. Some associations and companies, realizing an acknowledgement of some sort was required, issued releases either praising the GMP’s or noting them as the forward step they do represent.
It strikes me that there has been no consolidated industry statement to address any of these looming issues. The food industry, as an industry, has challenged the practicality of aspects of the ‘Bioterrorism’ legislation and its impact. Where have we been as an industry? (only 25 people attended one of the SupplyExpo sessions dealing with this subject.)
In the supplements sector, there has been no indication of strategy. In fact, there is sharp divide over the ephedra issue and how it should be managed, and there has been concern expressed over whether any of the trade associations are uncompromised enough to be able to represent the industry in dealing with GMP’s and other regulatory issues.
There are also a variety of views on the level of urgency the sector should feel, and that could be lethal. We’re facing two immediate windows with a third looming and a fourth implied.
- For the ephedra comment period – 30 days.
- For the GMP comment period – 90 days.
- For the Bioterrorism legislation - 7 months.
- For beginning to address, as an industry, a commitment to being responsible - no time at all.
Companies and the industry as a whole have been reacting - one step behind. The GMP’s and the ephedra comment period provide all with an opportunity to begin to execute a strategy, to demonstrate responsibility, a high road and small voluntary steps to diffuse future stories before they happen. Mainstream consumers will only deal with responsible companies. Food and nutrition companies will only work with companies with no associated risk.
While there are legitimate arguments to support a variety of courses of action, perhaps a nugget can be gained by Sun Tzu: The Art of War (Chapter 3, www.sonshi.com) :
‘Therefore, a smaller army that is inflexible will be captured by a larger one.’